Functional Electrical Stimulation in Chronic Ankle Instability

NCT ID: NCT04314960

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-23
• Study Completion Date: 2022-06-30

Brief Summary

Individuals with chronic ankle instability (CAI) display neuromuscular deficits such as altered control of posture and gait when compared with healthy controls. These deficits may be attributed to muscle inhibition occurring after a surrounding joint structure has been damaged. Functional electrical stimulation (FES) is the application of high-intensity intermittent electrical stimuli to generate muscle contractions that may overcome inhibition, and which is coupled with a functional task such as gait.

The current study aims to investigate the short and immediate effects of FES on gait parameters and postural control in subjects with CAI. Prior to intervention, treadmill gait will be evaluated using a motion analysis system, and postural control will be evaluated in a series of tests that measure balance, reaction time to ankle perturbation and stabilization ability after jump-landing. Then, a 20 minutes gait training with an FES device will be applied. Immediate effects of the training on gait parameters will be assessed. For medium-term effects evaluation, subjects will return for additional 7 training sessions (2 per week for 4 weeks), following by a complete measurements acquisition as prior to intervention. At six months follow-up, subjects will be contacted for collecting subjective outcomes.

Conditions

Joint Instability; Ankle Sprains; Sport Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAI subjects

Subjects in this group will receive eight 20-minutes gait training sessions with functional electrical stimulation.

Group Type: EXPERIMENTAL

Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA)

Intervention Type: DEVICE

Functional electrical stimulation (FES) is the application of high-intensity intermittent electrical stimuli to generate muscle contractions that may bypass spinal and supraspinal inhibition, and which is coupled with a functional task such as gait. Gait training will be conducted on a treadmill.

Interventions

Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA)

Functional electrical stimulation (FES) is the application of high-intensity intermittent electrical stimuli to generate muscle contractions that may bypass spinal and supraspinal inhibition, and which is coupled with a functional task such as gait. Gait training will be conducted on a treadmill.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. A history of at least one significant ankle sprain:

1. At least 12 months prior to participating in the study

2. Was characterized by inflammatory symptoms (i.e. pain and swelling)

3. Caused at least one day of decreased physical activity

2. At least 3 months since the last acute ankle sprain that results in inflammatory symptoms and at least one interrupted day of desired physical activity.

3. History of the previously injured ankle 'giving way' at least twice during the last 6 months, and/or 'feelings of instability' and/or recurrent sprain.

4. Being able to bear full weight on the injured lower extremity with no more than mild discomfort.

5. Scoring<24 in the Cumberland Ankle Instability Tool (CAIT)

Exclusion Criteria

1. A history of previous surgeries to a musculoskeletal structure in either lower limb.

2. A history of a fracture requiring re-alignment

3. Any acute injury to a lower limb in the last 3 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shmuel Springer

OTHER

Sponsor Role: lead

Responsible Party

Shmuel Springer

Chair, Physiotherapy Department, Neuromuscular & Human Performance Laboratory

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shmuel Springer, PhD

Role: PRINCIPAL_INVESTIGATOR

Ariel University

Locations

Ariel University

Ariel, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Uri Gottlieb, MSc

Role: CONTACT

urigott@gmail.com

+972542022767

Facility Contacts

Uri Gottlieb

Role: primary

urigott@gmail.com

0542022767

Other Identifiers

AU-HEA-SS-20200308a

Identifier Type: -

Identifier Source: org_study_id